FDA panel backs anemia drugs for kidney disease
Tuesday, October 26, 2010
ADELPHI, Md. (AP) — Federal health advisers said last week that patients with failing kidneys should continue taking a group of widely used anemia drugs, despite a recent study showing they can increase the risk of stroke.
A panel of Food and Drug Administration experts voted 15-1, with one abstention, to maintain the drugs’ approval for patients with chronic kidney disease who are not yet sick enough to receive dialysis. The FDA is not required to follow the group’s advice, though it often does.
The medicines — Procrit, Aranesp and Epogen — are multibilliondollar sellers because of their ability to boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten death in cancer patients. The drugs are no longer used in patients with several types of cancers.
The FDA is reviewing the medications from biotech drugmaker Amgen Inc. after a study published last year that showed patients with kidney disease who were taking the drugs were twice as likely to experience stroke compared with those taking a dummy treatment. The goal of the study was to show that higher doses of the drug could prevent heart attack, stroke and other heart-related problems, as had been assumed for years.
Doctors adjust their patients’ drug doses to maintain healthy levels of hemoglobin, a component of blood that carries oxygen and keeps anemia patients active.